SPOTTEST LOEFFLER METHYLENE BLUE STAIN— 510(k) K843919

Name: FDA 510(k) clearance K843919
Creator: U.S. Food and Drug Administration
Published: 1984-10-30

Substantially Equivalent

Difco Laboratories, Inc.

FDA 510(k) clearance K843919 for SPOTTEST LOEFFLER METHYLENE BLUE STAIN, Substantially Equivalent on 1984-10-30. Applicant: Difco Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Difco Laboratories, Inc.
Product code: Code KFC
Device class: Class 1
Regulation: 21 CFR 864.1850
Advisory panel: Hematology
Date received: 1984-10-05
Decision date: 1984-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Detroit, MI, US

Download summary PDF View on FDA.gov ↗

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K875310 — RETICULOCYTE STAIN1988-02-09
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K842926 — METHYLENE BLUE STAIN, LOEFFLER1984-09-11
K842743 — NEW METHYLENE BLUE N1984-08-12
K831502 — NEPHROLYTE1983-07-18

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